SUREFIRE SCORPION NEEDLE

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 11/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE WAS BENT ON THE FIRST SHOT WITHOUT ALLOWING THE SUTURE TO PASS THROUGH. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS THAT THE DISTAL END OF THE NEEDLE WAS BENT. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. DFU-0392-SUB-EO WARNS AGAINST THE USAGES LISTED TO HELP AVOID NEEDLE BREAKAGE AND POTENTIAL PATIENT INJURY. THE MOST LIKELY CAUSE THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING FIRING OF THE NEEDLE THUS, BREAKING THE NEEDLE.